Senior Director, Regional Clinical Study Management
New
Based in the United StatesFull-TimeDirector
SalaryCompetitive annual salary ranging from $206,200 to $276,200, depending on experience, qualifications, and location.
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Job Details
- Experience
- Minimum of 12+ years of progressive experience in clinical operations within biotech, pharmaceutical, or CRO environments, or 8+ years with advanced degree.
- Required Skills
- LeadershipMicrosoft OfficeStakeholder management
Requirements
- Bachelor’s degree in a scientific, healthcare, or related discipline required; Master’s degree preferred.
- Minimum of 12+ years of progressive experience in clinical operations within biotech, pharmaceutical, or CRO environments, or 8+ years with advanced degree.
- Extensive experience leading clinical study teams and managing complex, multi-regional clinical trials.
- Strong expertise in clinical study lifecycle management, including feasibility, start-up, execution, and closeout phases.
- Deep understanding of clinical trial regulations, including ICH-GCP, and requirements for inspection readiness and compliance.
- Proven leadership experience managing and developing teams in a matrixed, global environment.
- Strong stakeholder management skills with the ability to influence senior leaders and cross-functional partners.
- Excellent analytical, problem-solving, and decision-making abilities in complex operational environments.
- Proficiency in clinical operations tools, reporting systems, and Microsoft Office applications.
- Willingness to travel as required to support regional and global clinical activities.
Responsibilities
- Provide regional leadership for clinical study management teams, ensuring effective execution of assigned study portfolios across all phases from feasibility to closeout.
- Oversee study delivery to ensure adherence to timelines, budget, quality standards, and regulatory requirements, including ICH/GCP compliance and inspection readiness.
- Lead and mentor regional clinical study managers, fostering high performance, professional development, and strong team engagement.
- Act as escalation point for complex issues, driving resolution and ensuring alignment across regional and global stakeholders.
- Collaborate with global clinical operations, medical affairs, regulatory, biometrics, and supply chain teams to ensure seamless study execution.
- Drive regional study planning, including feasibility assessments, country and site selection, recruitment strategies, and operational alignment.
- Ensure robust oversight of data quality, study metrics, and operational performance.
- Develop and refine regional processes, SOPs, and best practices to improve efficiency and consistency across clinical study operations.
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